Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.
Abbott Rapid Diagnostics is part of Abbott’s Diagnostics family of businesses, bringing together exceptional teams of experts and industry leading technologies to support diagnostic testing which provides important information for treatment and management of diseases and other conditions.
The position of Associate Manufacturing Line Quality Engineer is within our Infectious Disease Developed Markets business unit located at Westbrook, ME. In this role you will provide support for product quality assurance, process improvements and all quality system program at the Westbrook Site.
Responsibilities

• Qualifications and Validations:
• Review qualifications, validations, and other studies for technical content, statistical and sampling rationale, unintended impact and clarity. Act as the Quality representative for qualification and validation approvals for all validated equipment.
• May administer or support the Quality Incidents and CAPA reporting program as follows:
• Coordination of the Scarborough Material Review Board (MRB): Develop and maintain processes for managing nonconforming materials and processes, including linking these events to lot history records and material transactions.
• Act as the Quality representative in the review and disposition of non-conformances, assuring appropriate decisions, testing, data and records are completed.
• Act as a technical resource to assure customer-centric resolution to non-conformances.
• Supplier Management Program:
• Act as the Quality representative for day-to-day maintenance of supplier management documentation and processes.

• Design Changes:
• Act as the Quality representative for review and approval of reports and documents associated with design changes and may also act as Project Manager for Design Changes.
• Develop and support the Quality Assurance training programs.
• Develop test and inspection plans.
• Review and assess from a technical perspective the content of all manufacturing, process, procedure and material changes. Assist in process data collection and analysis, provide training in the use of statistical techniques as needed.

• Internal / External Auditor:
• Support the internal audit program, assuring its technical content and compliance to applicable standards.
• Participate in 1st party (internal) and 2nd Party (External) audits and track audit findings to completion.
• Provide support to the Operations group as necessary.

Education And Experience You’ll Bring

• Bachelor's degree in Engineering, Chemistry, Biotechnology, Life Science or other technical field or the equivalent combination of education and experience.
• 3 years’ experience in the medical device industry or regulatory function.

Preferred Qualifications

• Certified Quality Auditor (CQA) Certification

Competencies

• Knowledge of ensur and Agile programs.
• Working knowledge of Database software; Internet software; Inventory software; Spreadsheet software and Word Processing software.
• Working knowledge of FDA, cGMPs/QSR and ISO quality system requirements
• Strong technical writing skills and effective communication skills

An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce.We provide reasonable accommodation to qualified individuals with disabilities.
The base pay for this position is $48,000.00 – $96,000.00. In specific locations, the pay range may vary from the range posted.